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Completed

NCT Number: NCT03852030

Mind-Body Health in Uro-Oncology: Research Study

In this study, the researchers will examine the effects of post-mindfulness intervention email and text messages to promote maintenance of intervention effects over time in a uro-oncology sample (clinically localized prostate, kidney, and bladder cancer) of patients and spouses.

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Key information

Conditions

Prostate Cancer Bladder Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Kidney Cancer Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University, Chicago, Illinois, United States

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About this study

Participant accrual will occur at NorthShore University HealthSystem's John and Carol Walter Center for Urological Health. During or prior to an office visit, a potential subject and possibly his/her spouse will speak with the physician or research staff to assess interest in discussing the study. All eligible participants will be enrolled into an 8-week mindfulness-based stress reduction (MBSR) course. Because the course content focuses on training in mindfulness meditation (and not cancer-specific issues), the researchers will allow for mixed cancer classes. Prior to the first class, all participants will complete baseline standardized patient reported outcomes (PROs) of health related quality of life, and undergo blood collection via finger prick. Following participation in the 8-week course, participants will complete their 8-week PRO and bio-marker assessments in a similar manner, and will be randomized to either 4 months of: 1) weekly mindfulness-specific text or email messages related to course teachings, 2) weekly general/informational texts or emails about healthy living and lifestyle, or 3) no texts or emails. PRO and bio-marker assessments will also be administered at 6 months, and PRO measures will be collected at 12 months.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed with clinically localized or locally advanced prostate, kidney or bladder cancer OR the spouse/significant other (married or living together ≥ 1 year) of a person with prostate, kidney or bladder cancer
  • Spouses/significant others will only be included if their partners with cancer diagnoses will be participating
  • 18 years old or older
  • Proficient in comprehending spoken English. Proficient in reading and writing English.

Exclusion criteria

  • Is not able to receive email or text messages
  • History of diagnosed severe mental illness or hospitalization for chronic psychiatric reasons, as identified by referring physicians, such that participation in MBSR group activities would be contraindicated.
  • Vision- or hearing-impaired such that ability to listen to or observe MBSR course instructions is compromised.
  • Diminished cognitive skills as to render consent meaningless
  • Physical debilitation such that study participation would not be feasible or would create undue hardship.
  • Participation in the intervention arm of the preceding study, "Reducing Stress During Active Surveillance" EH09-202.

Treatment and study plan

Text or email message

Behavioral

Text or email messages sent to research participants

Primary outcomes

  1. change in fatigue using the PROMIS Fatigue questionnaire

    Time frame: baseline, 8 weeks, 6 months, 12 months

    Examine change in fatigue between the intervention arms by comparing the responses on the PROMIS Fatigue questionnaire

  2. change in depression using the PROMIS Depression questionnaire

    Time frame: baseline, 8 weeks, 6 months, 12 months

    Examine change in depression between the intervention arms by comparing the responses on the PROMIS Depression questionnaire

  3. change in anxiety using the PROMIS Anxiety questionnaire

    Time frame: baseline, 8 weeks, 6 months, 12 months

    Examine change in anxiety between the intervention arms by comparing the responses on the PROMIS Anxiety questionnaire

  4. change in sleep using the PROMIS Sleep Disturbance questionnaire

    Time frame: baseline, 8 weeks, 6 months, 12 months

    Examine change in sleep between the intervention arms by comparing the responses on the PROMIS Sleep Disturbance questionnaire

  5. change in physical function using the PROMIS Physical Function questionnaire

    Time frame: baseline, 8 weeks, 6 months, 12 months

    Examine change in physical function between the intervention arms by comparing the responses on the PROMIS Physical Function questionnaire

  6. change in stress using the State-Based Stress Visual Analogue Scale

    Time frame: baseline, 8 weeks, 6 months, 12 months

    Examine change in stress between the intervention arms by comparing the responses on the State-Based Stress Visual Analogue Scale

  7. change in mindfulness using the 5-Facet Mindfulness Sub-scales

    Time frame: baseline, 8 weeks, 6 months, 12 months

    Examine change in mindfulness between the intervention arms by comparing the responses on the 5-Facet Mindfulness Subscales

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • Endeavor Health

Registry information

Official study title

Mind-Body Health in Uro-Oncology: A Randomized Controlled Trial

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Feb 22, 2019
Registry last updated
Jun 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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